GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule

Main information

  • Trade name:
  • GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177708
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177708

GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Ferring Pharmaceuticals Pty Ltd

Postal Address

PO Box 315,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

14/05/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

13/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

GLYPRESSIN is indicated for the:

·treatment of bleeding oesophageal varices;

·treatment of patients with hepatorenal syndrome (HRS) Type 1 who are actively being considered for liver transplant.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

Components

1. GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colourless solution

Active Ingredients

Terlipressin

.85 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 11:05:52 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

GLYPRESSIN

®

Solution for Injection

Terlipressin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about GLYPRESSIN.

It does not contain all of the available

information. It does not take the

place of talking to your doctor, nurse

or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being given

GLYPRESSIN against the benefits

they expect it will have for you.

If you have any concerns about

using this medicine, ask your

doctor, nurse or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What GLYPRESSIN is

used for

GLYPRESSIN contains terlipressin.

GLYPRESSIN is used to treat

Bleeding Oesophageal Varices

(BOV), bleeding veins in the lower

end of the food-pipe in people with

serious liver disease. When the liver

is diseased, there is less blood

flowing through it. This causes the

blood to 'back up' in the veins in the

lower end of the food pipe (and

upper part of the stomach). The veins

in the lining of the food pipe (and

stomach) then become very large and

stretched, much like varicose veins.

Because the veins are also very

fragile, they can rupture and then

bleed severely into the stomach.

GLYPRESSIN contains terlipressin,

a substance which acts to stop the

bleeding by lowering the blood

pressure in the veins of the food-

pipe.

GLYPRESSIN is also used to treat

hepatorenal syndrome, type 1

(HRS-1). GLYPRESSIN is given

when a patient with HRS-1 is being

considered for a liver transplant.

HRS-1 is a condition in which the

kidneys suddenly fail to work in a

person with severe liver disease.

HRS-1 is a life-threatening

complication of severe liver disease.

The cause of HRS-1 is not fully

understood. It is thought to be due to

the kidneys drastically reducing their

own blood flow, in response to large

changes in blood flow in other parts

of the body caused by severe liver

disease.

GLYPRESSIN works in HRS-1 by

improving the blood flow in the

kidneys.

Ask your doctor if you have any

questions about why

GLYPRESSIN has been

prescribed for you.

Your doctor may have prescribed it

for another reason.

GLYPRESSIN is not addictive.

This medicine is available only with

a doctor's prescription.

Before you are given

GLYPRESSIN

When you must not be given

it

Do not use GLYPRESSIN if you

have an allergy to terlipressin, the

active ingredient, or to any of the

other ingredients listed at the end

of this leaflet.

Symptoms of an allergic reaction to

GLYPRESSIN may include:

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not use GLYPRESSIN if you

are pregnant.

It may affect your developing baby if

you are given it during pregnancy.

Do not use GLYPRESSIN if you

are breast-feeding or planning to

breast-feed.

It is not known if it passes into breast

milk or is safe for use in infants.

Do not use GLYPRESSIN after the

expiry date (EXP) printed on the

pack.

If you use it after the expiry date

has passed, it may not work as

well.

Do not use GLYPRESSIN if the

packaging is torn/damaged or

shows signs of tampering.

Before you are given it

Tell your doctor if you have

allergies to:

GLYPRESSIN SOLUTION FOR INJECTION

any of the ingredients listed at

the end of this leaflet

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

heart disease

high blood pressure

irregular heartbeat

circulation problems

kidney problems

you are on a controlled sodium

diet (this medicine contains 1.33

mmol (or 30.7 mg) of sodium

per ampoule)

Tell your doctor if you plan to have

surgery.

If you have not told your doctor

about any of the above, tell them

before you start taking

GLYPRESSIN.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and GLYPRESSIN

may interfere with each other. These

include:

beta blockers - used to treat high

blood pressure and certain heart

conditions

propofol, a short-acting

anaesthetic

sufentanil, a powerful opioid

painkiller (not available in

Australia).

Taking GLYPRESSIN with these

medicines may cause your heart to

slow down or beat irregularly.

These medicines may be affected by

GLYPRESSIN, or may affect how

well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines. Your doctor will advise

you.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking GLYPRESSIN.

How GLYPRESSIN is

given

How much you will be given

GLYPRESSIN is a medicine that is

used in hospital and should only be

administered by your doctor or nurse.

Your doctor will give you the correct

amount of GLYPRESSIN.

Your doctor may adjust the dose

depending on how you are

responding to the treatment.

The maximum dose is 1.7 mg every 4

hours (BOV) or every 6 hours

(HRS-1).

Instructions for proper use of the

drug intended for your doctor or

nurse are included in the package

insert.

How it is given

GLYPRESSIN will be given to you

by injection in one of your veins.

How often it is given

GLYPRESSIN is usually given for

up to 48 hours BOV.

GLYPRESSIN is generally used for

up to 2 weeks or less in treating an

occurrence of HRS-1.

If you are given too much

(overdose)

As GLYPRESSIN is given to you by

a nurse and under the supervision of

your doctor, it is very unlikely that

you will receive too much.

However, if you experience any

side effects after you are

discharged, immediately telephone

your doctor, or the Poisons

Information Centre (telephone

Australia 13 11 26 or New Zealand

0800 POISON or 0800 764766), or

go to Accident and Emergency at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you receive too much

GLYPRESSIN, you may experience

any of the following:

headache

pale skin

blue lips and fingernails

stomach pain or discomfort

nausea

diarrhoea.

While you are using

GLYPRESSIN

Things you must do

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are or have been

treated with GLYPRESSIN.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

or have been treated with

GLYPRESSIN.

Be sure to keep all your doctor's

appointments.

Your doctor will want to do blood

and other tests regularly to check on

your progress and detect any

unwanted side effects.

If you become pregnant while you

are being given this medicine, stop

taking/using it and tell your doctor,

nurse or pharmacist immediately.

Things that may help your

condition

Some self-help measures suggested

below may help your condition.

Talk to your doctor or pharmacist

about them:

alcohol - your doctor may advise

you to limit your alcohol intake

GLYPRESSIN SOLUTION FOR INJECTION

diet - eat a healthy diet which

includes plenty of fresh

vegetables, fruit, bread, cereals

and fish. Also eat less fat and

sugar

smoking - your doctor may advise

you to stop smoking or at least

cut down.

Side effects

Tell your doctor or nurse

immediately if you do not feel well

after you have GLYPRESSIN.

Like all medicines, GLYPRESSIN

can have side effects, although not

everybody gets them. Sometimes the

side effects can be serious, although

most of the time they are not. You

may need medical attention if you get

some of the side effects.

The hospital staff will be monitoring

you for possible side effects. If you

get some of the side effects, your

doctor and/or nurse will help you

manage them while you are in the

hospital.

Ask your doctor, nurse or pharmacist

to answer any questions you may

have.

Don't be alarmed by the following

list of side effects. You may not

experience any of them.

The most frequently reported side

effects are:

headache

increased blood pressure

slow, fast or irregular heart beat

pale skin

blue lips and fingernails

stomach pain or discomfort

diarrhoea.

Other side effects include:

local irritation at the injection site

difficulty breathing

hot flushes

chest pain

heart failure

feeling or being sick (nausea or

vomiting)

swelling due to excess fluid in the

body

Tell your doctor or nurse if you

notice anything else that is making

you feel unwell.

Other side effects, not listed above,

may also occur in some people.

After using

GLYPRESSIN

If you have any queries about any

aspect of your medicine, or any

questions regarding the

information in this leaflet, discuss

them with your doctor, nurse or

pharmacist.

Product description

What it looks like

GLYPRESSIN is given as

intravenous injection:

Solution for Injection

this is a clear, colourless solution

containing 8.5mL of

GLYPRESSIN solution (in an

ampoule)

available in a box containing 5

ampoules of GLYPRESSIN

solution.

Ingredients

Active ingredient:

The active ingredient in

GLYPRESSIN preparations is

terlipressin.

Each ampoule of GLYPRESSIN

Solution for Injection contains 0.85

mg terlipressin (equivalent to 1 mg of

terlipressin acetate) in 8.5 mL

solution.

Other ingredients:

Sodium chloride, Acetic acid,

Sodium acetate trihydrate, Water for

Injections

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Sponsor

GLYPRESSIN is supplied in

Australia by:

Ferring Pharmaceuticals Pty Ltd

ABN No. 87003 037 170

Suite 2, Level 1, Building 1

20 Bridge Street

Pymble 2073 NSW

Free phone: 1800 33 77 46

Website: www.ferring.com.au

Australian Register

Number(s):

GLYPRESSIN Solution for

Injection, ampoule:

AUST R 177708

Date of preparation

This leaflet was prepared in May

2016.

#28327-v5B

Registered Trademark of Ferring

GLYPRESSIN SOLUTION FOR INJECTION